Executive, Quality Assurance

1. Document Control:

- Ensure the issuance, distribution, and retrieval of obsolete and/or superseded documents are performed as per GMP requirements and approved the procedure.
- Preparing and distributing a copy of controlled documents immediately after the documents had been approved by QA.
- Control the secure retention of current and superseded masters of each document for the retention time nominated in the List of Control Documents.
- Retain the current and superseded master copy of documents (hard copy and soft copy) and destroy when it reaches the expiry limit.
- Manage the safe keep of original copies of documents such as, Operational Standard Procedure (SOPs) and Master Batch Records.
- Update all QA related Master Lists and log books.
- Ensure all SOP’s are updated as per SOP.: QA001: Document Control Procedure.
- Update approved document with watermark “Controlled Copy” and upload in PLS server for online distribution purpose and shredding the superseded document, filing, and archiving.
- Control the secure retention of current and superseded masters of each document for the retention time nominated in the List of Control Documents.
- Keep the master copies SOP, WI, drawings, master batch records etc.
- Monitor the status of the documents on the issue.
- Photocopy of original document and stamp copy number or Controlled Copy (when required) or Uncontrolled Copy.
- Submit the controlled copies (when required) to department office coordinator/secretary.

2. Batch Records issuance and maintenance:

- Create batch number card in ERP system before issuing Batch Record for Production use.
- Issue Batch Records to Production upon request by SCM.
- Review all relevant information in the Finished Product Batch Log.
- Paste Finished Goods Released Label to the released product.
- Paste On Hold Label to the affected product.
- Ensure batch records are properly stored - filed, arranged and stored.
- Retrieve batch records whenever requested.
- Dispose of batch records after the retention period exceeded (1 year after the product expiry date or 5 years whichever longer).

3. Manage general correspondence, procedures and other documents related to departmental operations.

4. Achieve compliance with Halal requirement, ISO requirements such as ISO 9001, ISO 14000, ISO 45001, ISO 17025, cGMP, and GDP requirements such as PIC/S, US-FDA, EU-GMP, EU-GDP and local regulatory and third-party principal requirements.

5. To manage contract agreement workflows, including tracking the status of agreements and providing notifications to end users to initiate or take action on agreements.

6.To maintain and update the status of the master list for all section units, ensuring that it remains current and accurate. The system should also provide reminders to end users for timely updates.

7.Conduct Scavenger Hunt/Gemba Walk, prepare report and follow up correction or corrective actions implemented when necessary

8.To manage all SAP related activities such as Material Master Form (MMF), release PO for BMR and BPR, MAL number and PIERS.

9.To manage activities related to the Material Master Form (MMF), including the issuance of material codes for Raw Materials, Packaging Materials, Finished Products, Semi-Finished Products, and Consumables in the SAP system.

10.To manage the creation of Internal Purchase Requisitions (IPR) for QA activities including audit-related payments.

11.Conduct training related to job scope.

12.Review and revise Standard Operating Procedure (SOP) related to job scope as and when required.

13.Undertake any other duties as directed by immediate superior and management as and when required.

**Job Types**: Full-time, Permanent

Pay: RM2,800.00 - RM3,500.00 per month

**Benefits**:

- Free parking
- Health insurance
- Maternity leave
- Meal allowance
- Professional development

Work Location: In person

Expected Start Date: 09/01/2025